Clinical Evaluation of the CARTO™ XP EP Navigation System v9 and Biosense Webster SOUNDSTAR 3D Diagnostic Ultrasound. A Feasibility Study

Biosense Webster

Status and phase: Withdrawn; Phase 2

Conditions: Cardiac Arrhythmias

Treatments: Device: CARTO™ XP EP Navigation System V9; Procedure: Electrophysiology

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00449085

RAH061225

Details and patient eligibility

About

Feasibility study to evaluate CARTO™ XP EP Navigation System V9 and SOUNDSTAR 3D Diagnostic Ultrasound Catheter.

Full description

To construct geometric representation of the heart chambers using intracardiac ultrasound.The Carto™ XP Electrophysiology (EP) Navigation System v9 is intended to acquire real-time catheter based cardiac electrophysiogical maps.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects undergoing any EPS study and or Ablation will be eligible for this study.

Age 18 years or older Signed Patient Informed Consent Form

Exclusion criteria

• Patients with inadequate vascular access

Patients with any of the following criteria will be excluded:

• Women who are pregnant

  • Age <18 years
  • Any Contraindication to the clinical procedure
  • Sepsis

• Major coagulation abnormalities

• Presence of any intracardiac thrombus

• Unstable angina

• Uncontrolled Heart failure

• Deep Vein Thrombosis

• Significant peripheral vascular disease

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)